WO2022258832A1 - Système d'entérostomie pour une évacuation contrôlée des selles - Google Patents

Système d'entérostomie pour une évacuation contrôlée des selles Download PDF

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Publication number
WO2022258832A1
WO2022258832A1 PCT/EP2022/065893 EP2022065893W WO2022258832A1 WO 2022258832 A1 WO2022258832 A1 WO 2022258832A1 EP 2022065893 W EP2022065893 W EP 2022065893W WO 2022258832 A1 WO2022258832 A1 WO 2022258832A1
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WO
WIPO (PCT)
Prior art keywords
base plate
enterostoma
stoma
cuff
ostomy bag
Prior art date
Application number
PCT/EP2022/065893
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German (de)
English (en)
Inventor
Jan-Erik MÜLLER
Original Assignee
Mueller Jan Erik
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Filing date
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Publication of WO2022258832A1 publication Critical patent/WO2022258832A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404—Details or parts
    • A61F5/4405—Valves or valve arrangements specially adapted therefor ; Fluid inlets or outlets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/4404—Details or parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/448—Means for attaching bag to seal ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/449—Body securing means, e.g. belts, garments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4455—Implantable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4486—Colostomy, ileostomy or urethrostomy devices with operable locking ring

Definitions

  • the invention relates to an enterostomy system for the controlled drainage of stool or excrement in the case of an artificial bowel outlet (artificial anus praeter sphincter), in particular for maintaining stool continence.
  • an artificial bowel outlet artificial anus praeter sphincter
  • the subject matter submitted relates to a medical device which is used in particular to supply permanent enterostomata to maintain continence with the aid of an artificial anus praeter sphincter.
  • enterostomy anus praeter
  • enterostomy means a surgically created opening in the abdominal wall, which allows the patient to continue to drain the stool.
  • a stoma bag usually glued to the surface of the abdomen by means of a plate serves as a receptacle for the uncontrolled excretion.
  • the permanent attachment and removal of the plate to change the ostomy bag causes skin irritation, which is a heavy burden for the patient. Additionally, fungal and bacterial infections in the peristomal area are difficult to treat because the use of antifungal tinctures can cause the system to leak. Due to the constant contact of this plate of the ostomy appliance with the peristomal skin surface, the resulting skin maceration acts as a catalyst for further infection.
  • the only improvement to this rudimentary system is a two-component system that allows patients to leave the base plate attached to the skin's surface for an extended period of time and merely replace the ostomy bag.
  • Implants that can produce fecal continence are, for example, the "Artificial Bowel Sphincter” (ABS) from the company A.M.S. (American Medical Systems)
  • An anal cuff is connected to a water-filled reservoir via a silicone tube, from which the anal cuff is filled using a pump or by squeezing out the balloon reservoir, so that the anal canal closes or opens again by emptying the cuff.
  • these systems are associated with high surgical costs and also high infection and penetration rates. Nevertheless, there is a significant improvement in continence performance and thus improves the quality of life of those affected. However, these systems can only be used if the stool can be drained via the physiologically vital anus canal. Also is the ABS not applicable to other layers in the body as it is intended for sublevatory space only.
  • An anus praeter with an ostomy bag arranged thereon for receiving stool and other intestinal contents are known per se.
  • the care of the stoma is unfamiliar to the patient and must be trained by the patient with the help of experienced medical staff in order to carry it out themselves every day.
  • a stoma bag is connected to the part of the body on which the artificial bowel outlet (stoma) was laid via an adhesive surface arranged on it.
  • two different techniques are used, whereby in a so-called one-piece supply the bag is firmly connected to an adhesive surface to be placed on the body. With this version, both the ostomy bag and the adhesive plate must always be replaced.
  • the adhesive surface or a base plate is separated from the ostomy bag and connected to it by a detachable connection such.
  • this type causes irritation in the so-called peristomal skin area, which is often difficult to avoid and difficult to heal.
  • Studies have shown that around 75% of people experience such peristomal skin complications. This often leads to pain, skin irritation and so-called infiltration.
  • the connection between the artificial anus and the ostomy bag is no longer completely sealed and unpleasant odors arise. The care of these skin complications requires a great deal of additional nursing time.
  • the aim of the invention is therefore to avoid the disadvantages described above and to provide an intestinal enterostoma closure system which is not only leak-proof, but with which the stool can also be discharged in a controlled manner, similar to the sphincter muscle in healthy people.
  • the intracorporeal part arranged in the body is arranged by the surgeon below the abdominal wall and comprises a mechanism for closing (occulusion) the intestine before it emerges from the artificial anus as well as an intracorporeal base plate or holding element arranged inside the abdominal wall for fastening the artificial end of the intestine or -starting. It also includes the entire arrangement also an extracorporeal part arranged outside the body, preferably a base plate, which rests tightly and firmly against the intracorporeal base plate or holding element arranged inside the body.
  • This part which is preferably designed as a base plate, has an opening which lies over the stoma and through which the contents of the bowel can escape.
  • the extracorporeal opening can be covered or closed by a cover or a cover plate or by the ostomy bag, as will be explained below.
  • the outer portion is preferably held in place with the baseplate placed inside the body by means of magnetic forces.
  • the outer part of the closure or closure device of the stoma is designed in such a way that a cover or closure of the intestinal outlet that also fits tightly is arranged on it.
  • This cover can also be removed and in its place an ostomy bag or a particularly aesthetically designed cover plate or closure plate can be placed or attached in a corresponding manner. Collected stool can then be discharged through this intestinal outlet in a targeted manner by opening the intestinal obstruction device located inside the body.
  • the intestinal obstruction device located inside the body can be based on various mechanical mechanisms and configurations.
  • One embodiment comprises a pneumatic system, in which a cuff is expediently provided which surrounds a section of the intestine in the form of a ring or tube and has lamellae which can be pumped up or inflated.
  • These lamellae are preferably ring-shaped, arranged around the intestine, which is also tubular. When the ring-shaped lamella is inflated, its inner diameter is reduced so much that it compresses the intestinal section in between so much that no stool can be transported further at this point.
  • several such lamellae are arranged one behind the other along the intestine, similar to swimming rings. A complete blockage of the intestine is ensured by the majority of these pressure or squeeze rings.
  • this pneumatic pressure device by means of a pump system such. B. inflated on the pump ball or a syringe, where if necessary the pressure can be released again and the closed intestinal section can be relieved again.
  • this system also includes a drain valve.
  • a pressurizing fluid simply air or other non-toxic fluid or gas compatible with the body can be used. It is therefore preferable to ensure that the pressure is adjusted in such a way that no necrosis occurs in the compressed area of the intestines arise.
  • a safety valve is therefore additionally arranged, which prevents the creation of too high a pressure due to an improper arrangement.
  • an intestinal closure device is to use a corresponding screw cap in the intestine, e.g. B. to arrange an iris shutter. Such a closure also seals the intestine against corresponding excretions. Specifically, this system is placed between and connected to two previously separated sections of the intestine by the surgeon.
  • ESV enterostoma closure system
  • the implant system according to the invention serves to restore stool continence and to conveniently change the ostomy bag.
  • the ESV enables independent outpatient ostomy care with controlled drainage of the stool into the ostomy bag and the unique opportunity to temporarily remove the ostomy bag during any activities.
  • the ESV includes a large number of other advantages, which are explained in more detail in the following description.
  • Surgical interventions are necessary to insert the enterostoma closure, which can preferably be carried out at the same time as creating a stoma.
  • the medical indication is given for the reason that the operation has to be performed anyway and the implantation of the ESV also promises advantages for the patient.
  • the oral and/or aboral end of the intestine must be covered with a close-fitting and controllable material (sleeve).
  • the remaining end of the intestine is then sewn to the abdominal wall.
  • the base plate which is provided with an opening for passage through the intestine, is fixed subcutaneously with the end of the intestine (stoma) in the abdominal wall, preferably with the aid of eyelets.
  • a hernia mesh can be used to further secure the base plate and stomas, also to preventively avoid hernias.
  • it is expediently made of a pliable, flexible material.
  • the ESV according to the invention is designed in such a way that the oral and/or aboral leg can be moved back in the case of a temporary ostomy or the position of the stoma can be changed if the bowel section is repeated, as is the case with Crohn's disease patients, for example.
  • the anus In the normal state, the anus is closed. When closed, the cuff compresses the bowel in a defined area or section so tightly that no stool can escape from the stoma (occlusion). To prevent necrosis, the pressure on the tissue must not be too great. Because the bowel is insensitive to pain, it can be touched and squeezed without concern.
  • the cuff preferably has a conical entrance shape, if necessary on both sides, which is intended to prevent the intestinal wall from overlapping (intestinal invagination) or over the cuff.
  • the mechanism is regulated by a pneumatic, hydraulic, mechanical, hydraulic-mechanical or pneumo-mechanical system.
  • the control mechanism can be connected extracorporeally by a plug-in mechanism to the implant via a catheter that is laid in the abdominal wall like a peritoneal catheter.
  • the valve can be exchanged and thus the pressure threshold value can also be varied. In this way it is possible to implant the entire system completely intracorporeally, thus minimizing the risk of infection.
  • the user controls the closure by squeezing the abdominal wall, while at the same time the reservoir is actuated and the cuff closes.
  • the filling level of the system can be adjusted to the anatomical conditions of the patient via a membrane on a pump ball in a minimally invasive manner using a cannula.
  • It is also possible to replace the control mechanism independently of the cuff using an adapter in the case of the fully intracorporeal system, the adapter connection can be separated by a laparoscopic procedure and the defective part can be removed. This is particularly advantageous if the function of the valve decreases over a long period of time and has to be exchanged or revised if necessary.
  • the ostomy bag is attached to the body with magnetic elements.
  • an extracorporeal baseplate which is in magnetic interaction with the intracorporeal baseplate.
  • the extracorporeal base plate has an opening which surrounds the stoma.
  • the ostomy bag is removably attached to this base plate.
  • the magnetic mechanism serves to attach the ostomy bag to the base plate in a user-friendly manner and as a drainage passage for the intestinal contents without the stool coming into contact with the peristomal skin. This small area of skin can have a major impact on the health and well-being of ostomy patients. By avoiding skin-faecal contact, peristomal skin irritation, infection and complications can be eliminated altogether.
  • the magnetic part of the enterostoma closure system in particular the intracorporeal base plate and/or the extracorporeal base plate, is preferably provided with magnets that are MRI-safe or MRI-compatible.
  • magnets that are MRI-safe or MRI-compatible.
  • diametric magnets are already known from other implanted prostheses and have been used successfully for a long time, particularly in cochlear implants.
  • diametric magnets are preferably embedded flexibly in a container made of synthetic material.
  • synthetic materials are, in particular, silicone or also plastics that are compatible with the body, and possibly also natural materials. This flexible mounting of the diametric magnets allows them to rotate in the strong magnetic field of an MRI and align them along the field lines. They are readily used at field strengths of up to 1.5 Tesla and even up to 3.5 Tesla.
  • the magnet is arranged in a particularly removable manner, specifically, if necessary, also in the intracorporeal base plate. This also makes it possible to remove the magnetic elements before an MRI scan in the case of extremely strong magnetic fields. This can be easily removed through the stoma opening by a surgeon or other medically trained personnel and later reinserted into the base plate or retaining plate.
  • the diametric magnets are freely rotatable and are usually magnetized horizontally, which means that the magnetization is parallel to the skin. Due to the mobility in the plastic or silicone cover, these magnets can rotate freely and thus align themselves with the external magnetic field.
  • the outlet or outlet closure lying on the outside of the abdominal wall and in magnetic communication with the extracorporeal base plate does not necessarily have to be equipped with MRI-compatible magnets. Since this can be easily removed before an MRI, it is possible to use simple normal magnetic or magnetizable materials here.
  • a sufficient magnet strength for the secure hold of the base plate and/or the ostomy bag is preferably secured by several diametral magnets. With the help of the diametrical magnets, the patient is still able to undergo a magnetic resonance tomography examination without having to remove the implant got to. This is because the magnets within the baseplate housing are free to rotate and interactions with the magnetic field that could result in a peripherally directed force are avoided.
  • the ESV according to the invention it is possible to select a magnet strength for the implant that is individually suitable for the patient. This is for example by measuring the thickness of the abdominal wall z. B. possible by means of a 2D ultrasound.
  • the pneumatic system is based on a cuff with a resilient, compliant inner radius and a rigid, less resilient outer surface.
  • the cuff should be placed at the aboral end of the small intestine or the oral end of the large intestine, at an appropriate distance from the abdominal wall so that the cuff encloses the intestine. Care should be taken to ensure that the tubular cuff is sufficiently clear of the abdominal wall so as not to induce tension on the stoma suture upon closure.
  • the stoma system can be sealed through the interaction of selected material properties and defined pressure fluid.
  • a pump bulb or a syringe, for example, which is already approved as a medical product (see FIG. 7), can be used to achieve the necessary pressure level.
  • the cuff material has functional, chemical and biological biocompatibility and is designed in such a way that no pathogenic biofilms can form on its surface.
  • the pneumatic pressure can be increased to a threshold value by the stoma patient using the mobile aids. When the set threshold is reached, the elastic material is stretched to such an extent that the intestine is compressed and closed. The pneumatic pressure is set in such a way that the system remains tight even with a low-viscosity stool, but necrosis in the compressed segment or
  • the mechanical system is based on a twist lock, e.g. B. an iris.
  • a twist lock e.g. B. an iris.
  • an iris closure is operated, which closes the stoma. Once rotated and the locking mechanism engaged, the urinary system is sealed to prevent leakage of fluids or feces.
  • the iris shutter can be opened and closed at will. Such a closure is operated and controlled using methods generally known to those skilled in the art.
  • the pneumo-mechanical lock is a combination of the two locking mechanisms described above.
  • the physiological structure of an anus is thus reconstructed in a lifelike manner.
  • closure of the stoma is only optional. It is also possible to leave the stoma in the open state and allow the ostomy bag to adhere to the skin surface until the next care interval. This wearing option is particularly useful while sleeping or in the home environment. A stoma bag change is possible at any time and can be carried out without an adhesive plate or contact between skin and stool.
  • the advantage of the ESV according to the invention is that in addition to the closure of the stoma, there is no adhesive mechanism and skin contact with the stool is avoided.
  • flatulence can be controlled, the stoma bag can be removed and the stoma can be opened and closed manually on an outpatient basis. After the intestine has been closed using one of the aforementioned mechanisms, it is possible to remove the ostomy bag and to cover the ostomy with a particularly aesthetic silicone cover, which may also have a magnetic holding mechanism.
  • the use of the closure and magnetic adhesion mechanism in a stoma care system makes it possible to change stoma bags quickly and easily, which can also be practiced in a mobile manner.
  • the interchangeable magnet ring allows the patient to find the appropriate magnet strength for the specific abdominal wall thickness and individual activity. Blind patients or patients with significant coordination difficulties are automatically and reliably positioned correctly using the magnetic force of attraction.
  • the often mirror-inverted stoma care is made much easier, especially if the stoma patient does not have a direct view of the stoma due to fat aprons.
  • the use of the closure mechanisms provided also results in a hygienic advantage, since an unintentional escape of body fluids from the supply system, for example when changing an ostomy bag, is avoided.
  • the closure of the stoma creates a backlog of stool in the intestine.
  • the stool remains in the intestine longer and molecules dissolved in water and other food components can be better absorbed from the extracorporeal area into the blood.
  • the improved absorption process leads to a firmer consistency of the excretion and helps the ostomy patient to achieve the desired optimization of nutrition and water balance.
  • a conical shape at the oral cuff entrance prevents overlapping of sections of bowel, known as bowel intussusception.
  • stoma patients are able to carry out leisure activities that would otherwise not be possible with a stoma bag or an open stoma. For example, cycling and jogging are much more comfortable without a stoma bag.
  • This primarily addresses young ostomy patients who still have a very high degree of mobility.
  • aesthetic coverage plays a key role in true intimacy. In this respect, but also with regard to everyday life as a whole, a significant contribution is made to eliminating the serious psychological stress associated with the clinical picture. In this way, the ostomy wearer gains a higher self-esteem and no longer has to subordinate everyday life to the symptoms.
  • the biological tissue described herein refers to soft tissue, skin tissue, subdermal tissue, subcutaneous tissue, fascia with muscle septa, ligaments and retinacula. However, the term biological tissue does not mean bone.
  • occlusion means the restoration of fecal continence and is not to be understood as a pathological condition.
  • the enterostomy closure (ESV) device for opening and closing an anus praeters includes a Adhesive mechanism of the ostomy bag, in particular without an adhesive mechanism, one or more of the following elements: a stool drainage system and an aesthetic cover, a closure cuff, a filling system or control system for filling and emptying a closure or occlusion cuff, a valve, a base plate with connection for a base plate, an ostomy bag, optionally with eyelets for its subcutaneous fixation, at least one magnetic component in the base plate, and optionally in the base plate of the ostomy bag, an aesthetic ostomy cover, a hernia mesh, a base plate with a removable ostomy bag, a hose system, the cuff and
  • the control system is fluidically coupled to one another, with the cuff being integrated in such a way that it encloses the intestine and can be operated with the aid of the closure system in such a way that
  • the inner radius of the cuff can be reduced by a fluid, with the cuff being connected to the control mechanism.
  • the cuff has a conical entrance shape that prevents parts of the bowel from slipping over one another (intestinal invagination) or over the cuff.
  • the control mechanism includes a valve assembly that allows the cuff inner radius to be controlled while maintaining a defined pressure threshold.
  • the base plate used in the system of the invention is preferably made of one material and is flexible so that it can be implanted with a small skin incision guide.
  • the pressure generated within the cuff preferably has a defined threshold which is not too high to prevent necrosis in the portion of bowel surrounded by the cuff, but high enough to establish continence.
  • the material of the inner radius of the cuff can be elastically deformed by the action of the fluid, it expediently having a smaller Shore hardness or thickness than the outer side of the cuff.
  • the base plate and the base plate of the ostomy bag suitably include a device that allows the ostomy bag to be attached to the abdominal surface without an adhesive mechanism, the strength of the adhesive force being adjusted to the skin thickness and activity of the ostomate by means of replaceable magnets in the base plate of the ostomy bag can be.
  • the base plate has magnets that are designed in such a way that imaging examinations, which are based, for example, on magnetic fields, can be carried out up to 1.5 Tesla and even up to 3 or up to 3.5 Tesla.
  • the base plate usually has eyelets that allow the implant to be attached subcutaneously to the abdominal wall, and there is a hole in the middle of the base plate, with the diameter of this hole being at least large enough to allow the oral and aboral ends of the thick and/or or- passes through the small intestine and can be attached to the abdominal wall.
  • the base plate of the ostomy bag comprises a device which allows the stool to be discharged into the ostomy bag and avoids contact between the stool and the skin surface.
  • the base plate of the ostomy bag may include a device that ensures quick and easy ostomy bag changing with adjustable magnet strength.
  • the cuff comprises chambers which are connected to one another with different resistances, so that the pressure within the chambers builds up and falls again at different rates.
  • the cuff consists of several compartments, some of which can be controlled and others are filled with a substrate in order to prevent punctiform loading of a section of the intestine and continence can be established with a lower threshold value.
  • the ostomy bag can be removed after continence has been established.
  • the stoma can then be covered with an aesthetic covering.
  • the cuff is not only suitable for terminal stomas, but also for double-barreled stomas thanks to a modification to a two-piece tube and cuff system, with the diameter of the base plate also being adjusted accordingly.
  • the control mechanism includes a valve that maintains the pressure threshold over the time of occlusion but does not allow inflation above the pressure threshold.
  • the control system of the cuff suitably has a direct or indirect connection which allows the patient to control the cuff mechanically, pneumatically, hydraulically, electrically, inductively, myoelectrically or a combination of the aforementioned mechanisms.
  • One embodiment of the stool control system for the anus praeter includes several components. Some of these components are implants and remain permanently in the body, while others are extracorporeal components designed to be removed and swapped out. Examples of implants are the cuff (107), a hose (105) that is particularly resistant to buckling, and a base plate (115) with magnets that can be removed if necessary.
  • a base plate (125) for fastening the ostomy bag (119) remains outside the body, in which a magnetic ring (120) can be inserted and replaced as required.
  • the ostomy bag (119) and possibly also the base plate (125) are intended as single-use products and are disposed of after use.
  • the cuff (107) is implanted around the intestine (31) and connected to a control mechanism via a tube (109). There is a valve (132) in the control mechanism which can maintain a defined pressure threshold. The occlusion of the bowel is carried out by increasing the pressure in the cuff. The occlusion of the bowel can be released at any time by opening the valve (132) on the control mechanism ). Magnets (113) are also distributed concentrically in the base plate (115) and cause the magnetic connection to the ostomy bag.
  • the cuff (107) comprises a series of lamellae or chambers (106) arranged one behind the other, which are connected to one another and which is divided into different hardnesses and coefficients of elasticity. This allows the inner diameter of the ESV cuff to adapt to the surface of the intestine and ensures a gentle occlusion.
  • the ESV system described in this patent application is intended for colostomy and ileostomy. Permanent terminal enterostomata should be given priority.
  • the diameter of the cuff (107) can be adjusted.
  • the base plate (115) and base plate (125) are also available in various dimensions, individually adapted to a patient.
  • FIG. 1 the ESV is illustrated as a completely intracorporeal system.
  • the intestine (31) is enclosed in the abdominal cavity-pelvis space (29) by the cuff with a conical entrance shape (102).
  • the inner radius of the cuff can be changed using the pump control (131) as a reservoir and valve (132), which is connected to the cuff by means of a hose (105).
  • the pump control is located in the pelvic cavity (29).
  • the intestine (31) is routed to the outside as anus praeter through the abdominal wall (30).
  • the base plate (115) is implanted in the abdominal wall and also encloses the intestine (31).
  • the magnetic ring (120) which is inserted in the base plate (125) of the ostomy bag (119) with the aid of pins (122), adheres to the abdominal wall (30) by means of magnetism.
  • the components mentioned above may deviate from the position shown.
  • Figure 2 shows the isometric view of the cuff (107) with a conical entrance shape (102) at the oral cuff end.
  • the outer radius (101) provides a stable shape during occlusion of the bowel.
  • the lamellar structures (103) inside the cuff can be controlled and elastically influenced, so that the inner radius of the cuff is reduced.
  • the aboral end of the cuff (104) is shaped in such a way that the smoothest possible transition is ensured.
  • the cuff is connected to the control mechanism of FIG. 7 by means of the hose system (105, 109), which is cut off here for the sake of illustration.
  • Fig. 3 shows an embodiment of the cuff without a conical entrance shape. For a more detailed view, this is shown as a side view (Fig. 3a) with inside edges.
  • the volumetrically changeable lamellar structures (106) can be observed, which are limited on the outside (107).
  • the cuff is connected to the control mechanism Fig. 7 via the hose system (109) illustrated. A fluid can be conducted through the volume inside the tube (110).
  • Fig. 4 shows the base plate (115) in a three-dimensional view. Concentrically arranged indentations (111) and peripheral eyelets (117) are included. The depressions (111) serve for the planar implementation of the diametral magnets (113) in the ventral biocompatible base plate surface (116). With the aid of the eyelets (117), the base plate (115) can be sutured subcutaneously into the abdominal wall on the fascia by guiding the suture thread through the opening (118). The embedded magnets (113) in the base plate ensure a magnetic adhesion mechanism with the magnetic ring (Fig. 6) of the ostomy bag (Fig. 5). The oral and/or aboral end of the intestine is led out through the opening (112). The entire base plate surface (116) prevents the formation of biofilms and thus the rejection of the implant.
  • FIG. 5 the structure of the ostomy bag (119) with built-in magnetic ring (Fig. 6) is illustrated. This is shown both in the rear view (Fig. 5a), in the side view (Fig. 5b) and as an isometric drawing (Fig. 5c).
  • the stool is discharged into the empty cavity of the ostomy bag (119).
  • the base plate (125) is designed in such a way that an exchangeable magnetic ring (120) with implemented magnets (121) can be clicked into suitable grooves (126) via two lugs (122).
  • a hygienic soft foam (124) hugs the stoma and reduces contact between the stool to be drained and the peristomal skin. Since the peristomal skin area should be kept as small as possible, the diameter of the ostomy bag opening (123) can be changed.
  • Fig. 6 shows the exchangeable magnetic ring (120), which can be inserted into the base plate (125) of the ostomy bag (119) with a precise fit. If the ostomy bag is changed, the patient takes the ostomy bag from the abdominal wall, turns the lugs (122) out of the grooves (126) provided, takes a new ostomy bag (119) and turns the lugs (122) back in Grooves (126) of the base plate (125) and finds the correct position via the attractive force between magnets (121) and (113).
  • Fig. 7 the pump control is shown.
  • This includes, among other things, a pump ball (131), which can also serve as a reservoir.
  • the fill level of the system can be adjusted via a membrane (137) by a minimally invasive intervention using a cannula.
  • the material of the pump ball (133) can be compressed using muscle power.
  • the valve (132) can be opened or closed with the aid of a button (136).
  • the aforementioned components are firmly connected to each other so that a fluid can flow through.
  • the hose (138) connects the valve to a female adapter (135). This female adapter (135) is connected to a male adapter (139).
  • FIG. 8 shows the arrangement of the ESV according to the invention in its position relative to the intestine (31) and abdominal wall (30) with cuff (107) and intracorporeal base plate (116, 115), extracorporeal base plate (125) and ostomy bag (119) attached thereto.
  • Figure 9 is an exploded view of the elements of Figure 8.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

L'invention concerne un système d'entérostomie pour une évacuation contrôlée du contenu intestinal dans un sac pour stomie au moyen d'un anus artificiel (stomie). Le système est caractérisé en ce qu'il comprend un dispositif d'occlusion de l'intestin commandable qui est disposé à l'intérieur du corps et une plaque de base intracorporelle qui contient l'anus artificiel est disposée à l'intérieur du corps, et est fixée à la peau et/ou à la paroi abdominale, et le système comprend une plaque de base extracorporelle qui repose de manière étanche contre l'anus artificiel depuis l'extérieur du corps ; la plaque de base intracorporelle étant maintenue en contact étanche avec la plaque de base extracorporelle par des aimants.
PCT/EP2022/065893 2021-06-11 2022-06-10 Système d'entérostomie pour une évacuation contrôlée des selles WO2022258832A1 (fr)

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DE102021003040.0 2021-06-11

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3565073A (en) * 1968-04-15 1971-02-23 Jerry D Giesy Method and means for attaching a body appendage
US4338937A (en) * 1980-12-05 1982-07-13 Lerman Sheldon H Mechanical continent ileostomy or colostomy
US4399809A (en) * 1979-10-30 1983-08-23 Baro Juan V Artificial sphincter for use at stoma, or for the like purposes
US20110015475A1 (en) * 2009-07-14 2011-01-20 Stimatix Gl Ltd. Inflatable stomal implant
US20130030397A1 (en) * 2010-02-01 2013-01-31 Saied Sabeti Medical device
US20150128962A1 (en) * 2012-05-18 2015-05-14 Centro Brasileiro De Pesquisas Fisicas - Cbpf Magnetic system for attaching and removing medical devices and prostheses on human skin

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3565073A (en) * 1968-04-15 1971-02-23 Jerry D Giesy Method and means for attaching a body appendage
US4399809A (en) * 1979-10-30 1983-08-23 Baro Juan V Artificial sphincter for use at stoma, or for the like purposes
US4338937A (en) * 1980-12-05 1982-07-13 Lerman Sheldon H Mechanical continent ileostomy or colostomy
US20110015475A1 (en) * 2009-07-14 2011-01-20 Stimatix Gl Ltd. Inflatable stomal implant
US20130030397A1 (en) * 2010-02-01 2013-01-31 Saied Sabeti Medical device
US20150128962A1 (en) * 2012-05-18 2015-05-14 Centro Brasileiro De Pesquisas Fisicas - Cbpf Magnetic system for attaching and removing medical devices and prostheses on human skin

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